The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Endocyte.
Device ID | K843941 |
510k Number | K843941 |
Device Name: | ENDOCYTE |
Classification | Brush, Endometrial |
Applicant | GYNECO, INC. 12 MINNEAKONING RD. Flemington, NJ 08822 |
Contact | Jeanine C Vigeant |
Correspondent | Jeanine C Vigeant GYNECO, INC. 12 MINNEAKONING RD. Flemington, NJ 08822 |
Product Code | HFE |
CFR Regulation Number | 884.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-09 |
Decision Date | 1985-02-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOCYTE 86152798 4813625 Live/Registered |
ENDOCYTE, INC 2013-12-26 |
ENDOCYTE 85306842 4412916 Live/Registered |
Endocyte, Inc. 2011-04-28 |
ENDOCYTE 74580945 1980224 Dead/Cancelled |
SHEAHON, JOHN A. 1994-09-30 |